The mammalian skin, in particular, human skin, is a multifunctional organ. Not only does the skin provide an external covering to protect the body, but it also performs several specialized functions, such as breathing, perspiring, sensory information processing, and oil production. D. Mowery, The Scientific Validation of Herbal Medicine, 248 (1986)!. Oil production, essential to the protective features of the skin, works when an oily substance known as sebum is released from the sebaceous glands, which are large glands located at the base of a hair follicle. This permits the skin to moisturize and waterproof itself, thereby protecting itself from the environment. J. Whitaker, Dr. Whitaker's Guide to Natural Healing, 141, (1995)!.
Unfortunately, puberty adversely affects the production of sebum, which in some cases is caused by increased levels of testosterone in both males and females. For example, testosterone stimulates the sebaceous glands accompanying the hair follicles. In response, these glands become enlarged and begin to secrete more sebum than usual. Also, testosterone causes the cells lining a pore to release more keratin, an insoluble protein that is the primary constituent of the hair and the epidermis. Together, the sebum and keratin block a skin pore, resulting in a comedone, also known as a blackhead. Bacteria proliferates in clogged pores, and the body typically responds by releasing enzymes to breakdown the sebum. The enzymes cause the pore to become inflamed. This eventually may result in pustules or pimples. This condition is typically known as acne vulgaris. Id.!. This response is especially prevalent on the face, back, and shoulders, where a greater amount of sebaceous glands exist.
Acne conglobate, more commonly known as nodular or cystic acne, is a more severe form of acne than acne vulgaris. In the case of nodular acne, the sebum builds up in the gland, mixes with dead cells, and eventually ruptures the follicle wall, which typically forms a deep cyst under the skin. Scarring often results from these deep cysts. Roche Laboratories Inc., Important Information Concerning Your Treatment with Accutane, 6th ed., (1996)!. Also, acne not only affects a person's appearance, but sometimes has detrimental affects on the person's psychological, social, and occupational status. P. Poshi, et. al., Report of the Consensus Conference on Acne Classification, J. Amer. Acad. Derm., 24/3/1-6 (March 1991)!. Present methods of treating acne attempt to address the three separate causes of acne: excess sebum production, keratinization disorders, and increases in the bacteria Propionibacterium acnes. R. Swain & B. Kaplan, Vitamins as Therapy in the 1990's, J. Am. Board Fam. Pract. 8:206-216 (1995)!.
Non-vitamin methods of addressing acne commonly attempt to curb acne by mitigating the sebum production through drying agents, such as alcohol and benzoyl peroxide. Additionally, antibiotics, applied topically or orally, such as benzoyl peroxide, erythromycin, clindamycin, or tetracycline are commonly used to control the bacteria. These methods often lead to overly dry skin, and relapse is common after treatment has ended. Id.!.
Vitamins and herbs often provide more promising results with regard to acne. Vitamin A has proven to be highly effective in treating acne. Since the early seventies, topical retinoic acid or tretinoin, both derivatives of vitamin A, have been used to treat acne topically. Id.!. These topical agents work by normalizing the skin's production of keratin and the sebaceous glands production of sebum, thereby preventing obstruction of the follicle. Although highly effective, the benefits of the topical treatment often take several weeks. Also, the patient's condition may become worse before clearing up. Finally, these topical treatments tend to have mild side effects, which include stinging and reddening of the treated areas and possible photosensitivity. Id. at 207!.
A systemic vitamin A derivative for the treatment of nodular acne, known as isotretinoin, is commercially available under the name ACCUTANE.RTM., from Roche Laboratories in Nutley, N.J. It has been found that treatment using isotretinoin can clear up as much as 85 percent of the acne over a 4 to 6 month period. Id.!. Also, the patient's condition tends to improve even after the treatment has ceased. Unfortunately, side effects often result from treatment using isotretinoin, and patients need to be monitored carefully. Monthly testing of the patient's liver, lipids and glucose is necessary to monitor the response to isotretinoin. The side effects are often mucocutaneous: cheilitis (dry, blistering lips), dry eyes or nose, eye irritation, pruritus, epistaxis (nosebleed), mild alopecia (hair loss), and some photosensitivity. Id.!. Furthermore, isotretinoin is teratogenic, and therefore posses a serious risk of causing birth defects in pregnant women. Birth defects such as craniofacial, cardiac, and central nervous system abnormalities may result from even small amounts of isotretinoin taken over short periods of time. Thus, doctors administering this treatment often require females to take effective contraception prior to, during, and after treatment. Roche Laboratories Inc., Important Information Concerning Your Treatment with Accutane, 6th ed., (1996)!.
Other minerals and vitamins are also thought to be effective in treating acne. Zinc is believed to be useful in the treatment of acne, because of its ability to aid in wound healing, immune response, inflammation control, tissue regeneration, and more effective utilization of vitamin A. Certain studies have shown that zinc produces results similar to tetracycline in the treatment of superficial acne, but far superior results with regard to deeper forms of acne. J. Whitaker, Dr. Whitaker's Guide to Natural Healing, 142 (1995)!. Also, certain nutrients, such as vitamin B.sub.6, selenium, and vitamin E, are thought necessary to healthy skin and, therefore, control acne. Id.!.
Also, herbs, such as sassafras and elder flowers, used both individually and in conjunction have been suspected of providing effective acne treatment. M. Tierra, Planetary Herbology, 154 & 158 (1988)!. Additionally, herbs possessing antibiotic properties, such as burdock root and horsetail, may individually aid in the treatment of skin blemishes, such as acne. D. Mowery, The Scientific Validation of Herbal Medicine, 32-33 (1986)!.
Several acne treatments exist that utilize the above vitamins, minerals, and herbs. AKNE-ZYME.TM., a nutritional supplement produced by one company, has been used in conjunction with a cleanser and topical cream to treat acne. The nutritional supplement contains zinc, vitamin A, vitamin C, and other natural elements that are believed to nourish the skin. Also, it is suggested that high doses of vitamin A are not needed in AKNE-ZYME.TM. as long as other nutritional factors such as zinc, vitamin B.sub.6, selenium, and vitamin E are incorporated into the acne treatment. J. Whitaker, Dr. Whitaker's Guide to Natural Healing, 141-142 (1995)!.
Also, an herbal treatment for acne has been suggested in The Scientific Validation of Herbal Medicine. D. Mowery, 247-51 (1986)!. The herbal treatment includes the following: chaparral, dandelion root, burdock root, licorice root, echinacea, yellow dock root, kelp, and cayenne. It is suggested therein that the herbal extract be used in conjunction with supplements of one or more of the following nutrients and minerals: vitamin A, vitamin B.sub.1, vitamin B.sub.2, vitamin B.sub.6, vitamin B complex, vitamin C, vitamin D, vitamin E, niacinamide, pantothenic acid, para-aminobenzoic acid, biotin, choline, inositol, folic acid, zinc, calcium, magnesium, and potassium. The reference further notes the possible use of the herbal supplement with a detoxifying herbal supplement, which contains burdock root and horsetail. Id. at 32-33 and 148!.
Although the above references disclose methods of treating acne, the treatments often involve adverse side effects, such as overdrying of the skin. Furthermore, the above treatments simply address the acne and fail to condition the skin cells to assist in the treatment and to reduce further incidences of acne. Thus, it is desired to find pharmaceutical compositions and methods for treating acne by administering the pharmaceutical compositions and conditioning the skin to inhibit further acne outbreaks without the adverse side effects present in many conventional acne treatments. The present invention, through a blend of herbal extracts and nutritional supplements, advantageously treats acne without adverse side effects, and conditions skin cells to reduce the likelihood of further acne.